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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04759105
Other study ID # ACTIVE trial_(BRIC2018-ID03)
Secondary ID 2019-004476-19
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 17, 2020
Est. completion date December 30, 2024

Study information

Verified date November 2023
Source Campus Bio-Medico University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

ACTIVE is a phase II B efficacy monocenter, prospective, randomized, controlled double blinded trial, in which intra-discal autologous adult BM-MSC therapy will be compared with sham treated controls. This trial will evaluate the efficacy of intradiscal injection of autologous BM-MSCs in workers affected by chronic low back pain (LBP) unresponsive to conventional therapy. The efficacy will be evaluated 12 months after the treatment in terms of pain relief (VAS, Visual Analog Scale), functionality (ODI, Oswestry Disability Index), quality of life (SF36, Short Form - 36) and work ability index (WAI).


Description:

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Study Design


Intervention

Drug:
Autologous BM-MSC
intradiscal injection of autologous bone marrow mesenchymal stromal/stem cells
Other:
Sham Procedure
anaesthesia, no disc injection, no placebo injection

Locations

Country Name City State
Italy Campus Bio-Medico University of Rome Roma

Sponsors (3)

Lead Sponsor Collaborator
Campus Bio-Medico University Center for Outcomes Research and Clinical Epidemiology, Italy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain clinical relief Pain clinical reduction of at least 40 percent on Visual Analogic Scale (VAS) between baseline and month 12. VAS pain scale ranges from 0 to 100, where 0 represents no pain and 100 represents the worst pain imaginable. Baseline to month 12
Primary Functional disability index improvement Functional disability reduction of 40 percent on Oswestry Disability Index (ODI, also known as the Oswestry Low Back Pain Disability Questionnaire) at month 12 compared with baseline. ODI scale ranges from 0 to 50 and allows evaluation of disability (0 - 20 percent: minimal disability; 20 - 40 percent: moderate disability; 40 - 60 percent: severe disability; 60 - 80 percent: crippled; 80 - 100 percent: bed-bound or exaggerating their symptoms). Baseline to month 12
Primary Work ability improvement Improvement of 10 percent on Work Ability Index (WAI) at month 12 compared to baseline. The WAI is composed of 7 items and is a validated instrument that assesses the individual work ability of an employee. The total WAI score ranges from 7 to 49 and is calculated by summing up the scores of the 7 items. Baseline to month 12
Secondary Measure pain relief of the patient Assessed by Visual Analogic Scale (VAS). VAS pain scale ranges from 0 to 100: where 0 represents no pain and 100 represents the worst pain imaginable. Baseline, 1, 3 and 6 months
Secondary Measure functional disability index of the patient Assessed by ODI (Oswestry Low Back Pain Disability Questionnaire) scale which ranges from 0 to 50 (0 - 20 percent: minimal disability; 20 - 40 percent: moderate disability; 40 - 60 percent: severe disability; 60 - 80 percent: crippled; 80 - 100 percent: bed-bound or exaggerating their symptoms). Baseline, 1, 3 and 6 months
Secondary Evaluate disability and quality of life evolution of the patient Assessed by Short Form-36 Health Survey (SF-36) scores which consist of eight 0-100 scaled scores (vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning and mental health) where a lower score corresponds to more disability and a higher score corresponds to less disability. Baseline, 1, 3, 6 and 12 months
Secondary Disability and quality of life evolution Assessed by the patient and the physician on: pain intensity in the lumbar spine (1 = none, 2 = mild, 3 = moderate, 4 = severe, 5 = extreme); patient's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor); physician's global assessment of disease activity (1 = very good, 2 = good, 3 = fair, 4 = poor, 5 = very poor). Baseline, 1, 3, 6 and 12 months
Secondary Assess rescue painkillers medication Rescue medication use will be recorded throughout the study duration by a diary file. Baseline, 1, 3, 6 and 12 months
Secondary Structural assessment Evolution of affected disc(s) by quantitative Magnetic Resonance Imaging (MRI) density measurements with T2 mapping protocol used as an indication of disc fluid and glycosaminoglycans (GAG) content. In addition MRI spectroscopy will provide an assessment of the chemical changes associated with disc degeneration. The "quality" of the patient's lumbar disc will be monitored non invasively using T2 weighted MRI sagittal images and T1spin/echo MRI at the same time points. Lumbar disc grading will be performed in the sagittal T2 weighted images by two experienced physicians independently, who will review each intervertebral disc (from L1-2 to L5-S1) by the modified Pfirrmann criteria. Baseline, 1, 3, 6 and 12 months
Secondary Evaluation of cost Comparison of medical and non-medical costs between the two groups of patients. Resource used in each arm will be collected in physical units in the eCRF at the clinical centre as follows:
Acute care medical hospitalisations related to IDD
Acute care surgical hospitalisations related to IDD
Rehabilitation hospitalisations related to IDD
Analgesics
Work disruption
12 months
Secondary Incidence of Adverse Events (AE) Report of Adverse Events (AE). If the study patients do not spontaneously report any AE occurrence since their last visit, they will be interviewed by the investigator filling a study-specific AE checklist for recording of symptoms and complaints. Baseline, 1, 3, 6 and 12 months
Secondary Assessment of vital signs During each visit to the study centre, patients will undergo a physical examination with recording of vital signs (temperature, blood pressure, heart rate, height and weight). Baseline, 1, 3, 6 and 12 months
Secondary Evaluation of blood and urine analysis During each visit to the study centre, patients will undergo blood sampling for assessment of routine lab tests (Haematology and Biochemistry) and urine analysis (dipstick). Baseline, 1, 3, 6 and 12 months
Secondary Analysis of chemical biomarkers for tissue degeneration Assessment of chemical biomarkers for tissue degeneration through MRI spectroscopy. MRI spectroscopy will be used to provide an assessment of the chemical changes associated with disc degeneration (Zuo et al. 2009). Baseline, 3, 6 and 12 months
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